Cartridge Insertion Mechanism for a Fluid Delivery Device

ABSTRACT

A fluid delivery device comprises a drive unit including an actuator and one or more first features and a cartridge filled with a fluid prior to being inserted into the housing. The cartridge having a fluid reservoir sealed at one end by a movable piston and sealed at another end by a pierceable septum. The cartridge includes one or more second features that are configured to align and mate with the one or more first features allowing the cartridge to be inserted into the drive unit. The piston is moveable by the actuator once the cartridge is inserted into the drive unit.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims the benefit of U.S. Provisional PatentApplication No. 62/063,979 filed Oct. 15, 2014 entitled “CartridgeInsertion Mechanism for a Fluid Delivery Device”, which is incorporatedby reference herein in its entirety.

BACKGROUND OF THE INVENTION

The present invention generally relates to cartridge insertionmechanisms for fluid delivery devices and, more particularly, tocartridge insertion mechanisms for ambulatory fluid delivery pumps fordelivering a medicament to a patient.

BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWINGS

The following detailed description of embodiments of the cartridgeinsertion mechanisms for a fluid delivery device, will be betterunderstood when read in conjunction with the appended drawings ofexemplary embodiments. It should be understood, however, that theinvention is not limited to the precise arrangements andinstrumentalities shown.

In the drawings:

FIG. 1 is a trimetric view of a fluid delivery device;

FIG. 2 is a top cross sectional view of the fluid delivery device shownin FIG. 1 taken along a plane indicated by line 2-2;

FIG. 3A is a front cross sectional view of the fluid delivery deviceshown in FIG. 1 taken along a plane indicated by line 3A-3A and shown inthe initial position;

FIG. 3B is a front cross sectional view of the fluid delivery device ofFIG. 3A shown in the deployed position;

FIG. 4 is a trimetric view of a fluid delivery device with an insertablecartridge in accordance with an exemplary embodiment of the presentinvention illustrating the cartridge being inserted;

FIG. 5 is a trimetric view of the fluid delivery device and thecartridge of FIG. 4 shown with the housing removed;

FIG. 6 is a trimetric view of the fluid delivery device and thecartridge of FIG. 4 shown with the cartridge inserted;

FIG. 7 is a trimetric view of the fluid delivery device and thecartridge of FIG. 4 shown with the cartridge inserted and the housingdoor closed;

FIG. 8 is a cross sectional trimetric view of the fluid delivery deviceand the cartridge of FIG. 4;

FIG. 8A is an enlarged cross sectional view of the piston end of thecartridge shown in FIG. 8;

FIG. 9 is a cross sectional trimetric view of the fluid delivery deviceand the cartridge of FIG. 7;

FIG. 9A is an enlarged cross sectional view of the piston end of thecartridge in the fluid delivery device shown in FIG. 9;

FIG. 10 is a cross sectional trimetric view of the fluid delivery deviceand the cartridge of FIG. 7 shown with the hydraulic fluid path opened;

FIG. 11 is a cross sectional trimetric view of the fluid delivery deviceand the cartridge of FIG. 7 shown with the hydraulic fluid path openedand the septum pierced by the delivery needle; and

FIG. 12 is a trimetric view of a fluid delivery device with aninsertable cartridge in accordance with an exemplary embodiment of thepresent invention having a cover door connected to the cartridge.

DETAILED DESCRIPTION OF THE INVENTION

Referring to FIGS. 1-3B, an exemplary fluid delivery device 110 isshown. In one embodiment, fluid delivery device 110 is a discreteambulatory insulin delivery pump. Fluid delivery device 110 may besingle use, disposable and incapable of reuse. Fluid delivery device 110may provide therapeutic capability in a small, single use, disposablepackage and can be produced using high volume manufacturing fabrication(e.g., injection molding) and assembly processes, allowing for low costof goods. Devices of the invention can be used for a broad range ofapplications, including, but not limited to, clinical applications(e.g., administration of medicaments, etc.) and biomedical research(e.g., microinjection into cells, nuclear or organelle transplantation,isolation of single cells or hybridomas, etc.).

In one embodiment, fluid delivery device 110 is a device for dispensing,delivering, or administering the fluid or agent to the user or patient.The fluid may be a low viscosity gel agent and or a therapeutic agent.In one embodiment, the fluid is an analgesic agent. In one embodiment,the fluid is insulin of any type. In one embodiment, the fluid is a U100insulin. In another embodiment the fluid is a U200 insulin. In anotherembodiment, the fluid is a U300 insulin. In another embodiment, thefluid is a U500 insulin. In another embodiment, the fluid is any insulinbetween U100 and U500. In other embodiments, the fluid may be, but isnot limited to, opiates and/or other palliatives or analgesics,hormones, psychotropic therapeutic compositions, or any other drug orchemical whose continuous dosing is desirable or efficacious for use intreating patients. Single fluids and combinations of two or more fluids(admixed or co-administered) may be delivered using fluid deliverydevice 110. As used herein “patients” or “user” can be human ornon-human animals; the use of fluid delivery device 110 is not confinedsolely to human medicine, but can be equally applied to veterinarianmedicine.

Fluid delivery device 110 may dispense the fluid over a sustained periodof time (i.e., basal delivery). In one embodiment, the fluid deliveryrate is continuously or near continuously delivered to the user over thesustained period of time. Fluid delivery device 110 may also be capableof dispensing a supplementary amount of fluid, in addition to the basalamount, on demand, under patient control (i.e., bolus delivery). In oneembodiment, the bolus amount delivered in a single, selectableadministration is pre-determined. In preferred embodiments, fluiddelivery device 110 is hydraulically actuated and comprises one or morereservoirs or chambers containing hydraulic fluid of a suitableviscosity for transferring power from one or more actuators to the fluidand controlling the delivery rate as discussed further below.

Referring to FIG. 1, for example, the fluid delivery device 110 shownincludes a housing 112 and an adhesive bottom surface 114 such as a foampad.

Referring to FIG. 2, fluid delivery device 110 includes a cartridge 222having a fluid reservoir 220 containing the medicament. The fluiddelivery device 110 may include one or more actuators 226 (such as abasal actuator), 228 (such as a bolus actuator) that act on piston 224within cartridge 222.

Referring to FIGS. 3A and 3B, a needle 330 may be deployed to fluidlycouple fluid reservoir 220 and the patient. Needle 330 may be coupled toa button 332 and the needle 330 may be bent such that a translation ofbutton 332 toward the patient causes a fluid coupling end 330 a to befluidly coupled to fluid reservoir 220 and a delivery end 330 b toextend from bottom surface 114.

Liquid pharmaceuticals for subcutaneous delivery mendicants are commonlypackaged in cartridge or vials having a fluid reservoir. It is desirableto be able to load these prefilled cartridges into a fluid deliverydevice for ease of handling rather than have to fill a reservoir alreadyinside of the device.

The cartridges commonly have a septum seal on one end and a piston orplunger inside at an opposite end. The medicament is delivered byfluidly connecting the material inside of the cartridge through theseptum with the patient's body and then pressing on the piston.

In most fluid delivery systems, and especially in hydraulically drivenfluid delivery devices, the accurate and effective delivery of themedicament requires that there be little, and preferably no,compressible gaps between the drive mechanism and the piston, little,and preferably no, pre-delivery pressure on the piston and that theneedle be accurately inserted into the septum.

Inserting a cartridge in a delivery device can result in performanceissues due to the length tolerance of the cartridge resulting inunacceptably large gaps that are compressible between the drivemechanism and the piston and a misaligned needle insertion system.

In addition, temperature changes in storage and transport may causechanges in component dimensions and liquid volumes. If there is asignificant difference in the coefficients of thermal expansion betweencomponents, then there may be significant changes in the componentspositions which could exacerbate tolerance issues. This is especiallysignificant in hydraulically driven systems where the fluid is likely tohave much greater thermal expansion characteristics than the solidcomponents of the device.

It is therefore desired to have a simple to use mechanism that allows aprefilled fluid reservoir or cartridge to be inserted in a deliverydevice, create a fluid seal to the device minimizing compressible gapsbetween the drive mechanism and the piston. In one embodiment, thelength tolerance of the cartridge usable with the delivery device is atleast +/−0.4 mm. The delivery device may allow for minimal pressure inthe system due to insertion or the insertion mechanism. The deliverydevice may allow for proper alignment between the cartridge septum sealand the needle mechanism. It is also beneficial if the delivery devicecan compensate for thermal expansion effects.

Referring to the drawings in detail, wherein like reference numeralsindicate like elements throughout, there is shown in FIGS. 4-12 fluiddelivery devices in accordance with exemplary embodiments of the presentinvention. Embodiments of the cartridge configuration may be used withvarious fluid delivery devices 110 (see FIGS. 1-3B) such as the fluiddelivery devices disclosed in U.S. Pat. No. 9,101,706, U.S. Pat. No.8,740,847, and U.S. Pat. No. 7,481,792 that are hereby incorporated byreference in their entirety.

In some embodiments, the fluid delivery device 110, 400 includes ahousing and a bottom surface configured to be coupled to a skin surfacein an engaged position. In one embodiment, a cartridge having a fluidreservoir is coupled to the housing and has a septum. In one embodiment,the septum seals one end of the fluid reservoir and a piston (see FIG.2) seals the other end. In one embodiment, the patient inserts apre-filled cartridge into the fluid delivery device prior to use. Theseptum of the cartridge may have a pierceable portion, the portion ofthe septum pierced by the needle during use. In one embodiment, thecartridge is comprised of glass, or has an inner glass coating, thoughother materials for the cartridge such as plastic may be used.

In some embodiments, a needle assembly having a needle may be used tofluidly couple the septum with the skin surface with the desired motionby the user or be configured to automatically deploy upon use of thedevice. The needle may have a delivery end and a fluid coupling end.Initially, the fluid coupling end may be fluidly disengaged from thefluid reservoir, (e.g., an initial or pre-fluid delivery position). Thedelivery end of the needle may also be spaced above the bottom surfaceof the fluid delivery device such that both ends of needle are containedwithin the housing in the initial position. After the fluid deliverydevice is adhered to the skin surface in the engaged position, thedelivery end of the needle may be extended through the bottom surface ofthe fluid delivery device and the fluid coupling end of the needle maybe extended through the pierceable portion of the septum eithersimultaneously, at offset times or separately such that fluid reservoiris fluidly coupled with the patient during use (e.g., a deployed, in-useor fluid delivery position).

In some embodiments, where the system is driven by a fluid, the fluidmust be contained securely in the device prior to the cartridge beinginstalled. Once installed, the fluid or fluid driven element is operableto urge or push the cartridge piston with minimal and preferably nocompressible space between the two.

Referring to FIGS. 4-11, a first exemplary embodiment of a fluiddelivery device 400 is shown. The fluid delivery device 400 may comprisetwo main components, the hydraulic drive unit 401 and the insertableprefilled cartridge 420. In one embodiment, the cartridge 420 includes afluid reservoir 415, containing a medicament, sealed at one end with apiercable element 416 such as a septum held in place by a crimp cover417 and sealed at the other end by an internally movable piston 419 (seeFIG. 9). The cartridge 420 also may also include a keyed feature 418 atone end. In other embodiments, the keyed feature 418 is proximate themiddle and/or other end of the cartridge 420. In one embodiment, thekeyed feature 418 is part of a sleeve as shown in FIGS. 4-11, at thepiston end of the fluid reservoir 415 that is attached to the outersurface of the cartridge 420 and is configured to mate with thehydraulic drive unit 401 upon insertion of the cartridge 420 into thehydraulic drive unit 401. In one embodiment, the keyed feature 418 hasone or more features 418 a such as radially protecting indentationsand/or protrusions that are unique to the model of the cartridge thatmate with one or more corresponding features of the hydraulic drive unit401. This keyed configuration between the cartridge 420 and the driveunit 401 may help to prevent a cartridge 420 not intended for thespecific drive unit 401, such as a cartridge containing an undesirabletype or volume of medicament, from being inserted into the specificdrive unit 401.

In the embodiment shown in FIGS. 4-11, the features 418 a of thecartridge 420 include one or more groves that correspond with features421 such as protrusions of the drive unit 401. In other embodiments, thefeatures 418 a of the cartridge 420 also or alternatively includeprotrusions that correspond with the features 421 of the drive unit 401such as indentations. In one embodiment, the one or more features 418 aof the keyed feature 418 project radially inwardly and/or outwardlyrelative to a longitudinal axis A of the cartridge 420 and extend aroundthe entire circumference of the keyed feature 418 such that thecartridge 420 may be inserted into the hydraulic drive unit 401 in anyradial position about axis A. In other embodiments, the one or morefeatures 418 a, 421 extend only partially around the circumference ofthe keyed feature 418 and/or the drive unit such that the cartridge 420may only be inserted into the drive unit 401 in one or more discreteradial positions about axis A.

In one embodiment, the features 421 of the drive unit 401 are proximatethe seal receptacle 408 within the hydraulic drive unit. The drive unit401 may include an actuator that drives a hydraulic fluid configured todrive the piston 419. The drive unit 401 may be positioned within ahousing 402.

Referring to FIG. 8A, in one embodiment, the keyed feature 418 is aseparate part that is joined to the cartridge 420 with sufficientstrength to resist the maximum force applied to the reservoir by thehydraulic system. In one embodiment the keyed feature 418 is secured tothe cartridge 420 using an adhesive. In one embodiment, the keyedfeature 418 is secured to the cartridge 420 by a press fit. In oneembodiment, the keyed feature 418 is secured to the cartridge 420 by aswage of two pieces where an outer annular piece compresses an innerannular part around the reservoir when they the inner piece is pressedaxially into the outer annular piece. In one embodiment, the keyedfeature 418 is secured to the cartridge 420 by welding. In oneembodiment, the keyed feature 418 is secured to a preparatory surface onthe cartridge 420 such as a thin film, an etched surface or an adherentlabel. In one embodiment, the keyed feature 418 is secured to thecartridge 420 by a sleeve that slips over the end of the cartridge 420and at least partially over a portion of the seal 418 b. In oneembodiment, the keyed feature 418 is integrally formed into thecartridge 420.

FIG. 5 shows the fluid delivery device 400 with the housing removed toexpose the seal receptacle space 408. FIG. 6 show the cartridge 420inserted into the available space within the hydraulic drive unit 401.In one embodiment, a door 406 is coupled to the housing 402 andconfigured to be closed over the cartridge 420 to retain the cartridge420 in the drive unit 401 once the cartridge 420 is in place. The door406 may be configured to force the cartridge 420 into its fully seatedposition when the user closes the door 406 as shown in FIG. 7. In oneembodiment, there is an interlock that prevents the door 406 fromclosing without a cartridge 420 being at least partially inserted.

FIGS. 9 and 9A show a cross section of one embodiment in which thesubstantially keyed feature 418 is pressed into the seal receptaclespace 408 on insertion of the cartridge 420. In this embodiment, thereis a compliant portion or seal 418 b that slides along the rear surface408 a of the seal receptacle space 408. There are shoulders 408 b on theopposite end of the seal receptacle space 408 that fit with thecorresponding end of the keyed feature 418 to force the keyed feature418 and thus the seal 418 b against the rear surface 408 a effecting aseal between the rear surface 408 a and the piston end of the cartridge420. In one embodiment, the rear surface 408 a and the front surfaceshoulders 408 b of the seal receptacle space 408 are spaced a distanceapproximately equal to the distance between the front and rear of thekeyed feature 418. In one embodiment, the rear surface 408 a and thefront surface shoulders 408 b of the seal receptacle space 408 arespaced a distance less than the distance between the front and rear ofthe keyed feature 418 such that the seal 418 b is compressed against therear surface 408 a once the cartridge is inserted in the drive unit.

In one embodiment, the features 421 are spaced from the rear surface 408a a distance approximately equal to the distance the features 418 a arespaced from the end of the seal 418 b. In one embodiment, the features421 are spaced from the rear surface 408 a a distance less than thedistance the features 418 a are spaced from the end of the seal 418 bsuch that the seal 418 b is compressed against the rear surface 408 aonce the cartridge is inserted in the drive unit. By creating the sealforce through the fit of the keyed features 418, 421 the length of thecartridge 420 is not relevant to the creation of the hydraulic fluidseal. In one embodiment, the seal 418 b is continuous with the keyedfeature 418 and the compliance is a result of a thin feature on the endof the keyed feature 418. In one embodiment, the seal 418 b is ano-ring. In one embodiment, the seal 418 b is a second shot of compliantmaterial that is co-molded or over-molded with the keyed feature 418. Inone embodiment, the seal 418 b is a second part that is placed in afeature of the keyed feature 418. In one embodiment, the seal 418 b isintegral with the rear surface 408 a of the seal receptacle space. Inone embodiment, there is no compliant material and the fit and surfacequality of the keyed feature 418 and the surface 408 a of the sealreceptacle space 408 are sufficient to affect a seal for the hydraulicfluid.

In one embodiment, the keyed feature 418 is comprised of a material thatis less compliant than the seal 418 b. In one embodiment, the keyedfeature 418 is comprised of polycarbonate. In other embodiments, thekeyed feature 418 is comprised of plastics such as acrylonitrilebutadiene styrene (ABS), polypropelene, polysulphone, polyether etherketone (PEEK), nylon, polyethylene, acrylic, PVC and polystyrene. In oneembodiment, the seal 418 b is comprised of a thermoplastic elastomer(TPE) such as Pebax® with a durometer of less than Shore A 70. In otherembodiments, the seal 418 b is comprised of rubbers including butyl,nitrile and silicone.

In one embodiment, as shown in FIG. 9, the hydraulic fluid is not yet incontact with the rear end of the piston 419. The fluid is stillcontained within the hydraulic fluid manifold 404 by the hydraulic fluidvalve 407. In one embodiment, to bring pressurized hydraulic fluid incontact with the rear of the piston 419 the hydraulic valve 407 isopened by aligning the fluid path through the valve stem 407 a with thefluid path to the cartridge seal receptacle seal as shown in FIG. 10.

In one embodiment, to connect the medicament delivery path to thepatient, the supply end of the needle 430 is pressed through thepiercable element 416 as shown in FIG. 11 making the fluidic connectionbetween the inside of the cartridge 420 and the delivery needle 430.

Referring to FIG. 12, a second exemplary embodiment of the fluiddelivery device 1200 is shown. In one embodiment, the door 1206 issecured to the keyed feature 1218 and is part of the cartridge assembly1220. In one embodiment, the door 1206 and the keyed feature 1218 areintegrally connected. In one embodiment, the door 1206 and the keyedfeature 1218 are two parts but coupled together prior to insertion intothe hydraulic drive unit 1201.

In an alternative embodiment, the needle 430 and the needle supportsystem are secured to the door 1206 and the door to the keyed feature1218 prior to insertion into the hydraulic drive unit 1201.

It will be appreciated by those skilled in the art that changes could bemade to the exemplary embodiments shown and described above withoutdeparting from the broad inventive concepts thereof. It is understood,therefore, that this invention is not limited to the exemplaryembodiments shown and described, but it is intended to covermodifications within the spirit and scope of the present invention asdefined by the claims. For example, specific features of the exemplaryembodiments may or may not be part of the claimed invention and variousfeatures of the disclosed embodiments may be combined. Unlessspecifically set forth herein, the terms “a”, “an” and “the” are notlimited to one element but instead should be read as meaning “at leastone”.

It is to be understood that at least some of the figures anddescriptions of the invention have been simplified to focus on elementsthat are relevant for a clear understanding of the invention, whileeliminating, for purposes of clarity, other elements that those ofordinary skill in the art will appreciate may also comprise a portion ofthe invention. However, because such elements are well known in the art,and because they do not necessarily facilitate a better understanding ofthe invention, a description of such elements is not provided herein.

Further, to the extent that the methods of the present invention do notrely on the particular order of steps set forth herein, the particularorder of the steps should not be construed as a limitation on theclaims. Any claims directed to the methods of the present inventionshould not be limited to the performance of their steps in the orderwritten, and one skilled in the art can readily appreciate that thesteps may be varied and still remain within the spirit and scope of thepresent invention.

I/We claim:
 1. A fluid delivery device comprising: a drive unitincluding an actuator and one or more first features; and a cartridgefilled with a fluid prior to being inserted into the housing and havinga fluid reservoir sealed at one end by a movable piston and sealed atanother end by a pierceable septum, the cartridge including one or moresecond features that are configured to align and mate with the one ormore first features allowing the cartridge to be inserted into the driveunit, the piston being moveable by the actuator once the cartridge isinserted into the drive unit.
 2. The fluid delivery device of claim 1,wherein the actuator is a hydraulically driven actuator and thecartridge is sealed to the drive unit by a seal.
 3. The fluid deliverydevice of claim 2, wherein the seal is secured to the fluid reservoir bya sleeve that slips over the cartridge and at least partially over aportion of the seal.
 4. The fluid delivery device of claim 3, whereinthe sleeve includes the one or more second features.
 5. The fluiddelivery device of claim 2, wherein the seal is coupled to the one ormore second features.
 6. The fluid delivery device of claim 2, whereinthe seal is a ring secured to an exterior of the cartridge.
 7. The fluiddelivery device of claim 2, wherein the seal is an integral feature ofthe cartridge.
 8. The fluid delivery device of claim 2, wherein the sealincludes at least two pieces that are coupled together from opposinglateral sides of the cartridge and create a friction fit with thecartridge.
 9. The fluid delivery device of claim 2, wherein the sealincludes a first compliant portion proximate an end of the cartridge anda second compliant portion, the second compliant portion being lesscompliant than the first compliant portion and including the one or moresecond features.
 10. The fluid delivery device of claim 2, wherein atleast one of the one or more first features and/or at least one of theone or more second features includes a tapered lead-in configured tohelp guide the cartridge into place during insertion and compress theseal against the cartridge.
 11. The fluid delivery device of claim 2,wherein the seal is provided on the end of the cartridge and mating theone or more second features with the one or more first featurescompresses the seal against the drive unit to seal the cartridge to thedrive unit.
 12. The fluid delivery device of claim 1, wherein thecartridge includes a longitudinal axis and the one or more firstfeatures and the one or more second features include one or moreradially projecting protrusions and/or indentations relative to thelongitudinal axis.
 13. The fluid delivery device of claim 1, wherein theone or more first features are generally rectangular projections and theone or more second features are grooves configured to intermesh with thegenerally rectangular projections.
 14. The fluid delivery device ofclaim 1, wherein the one or more first features are grooves and the oneor more second features are generally rectangular projections configuredto intermesh with the grooves.
 15. The fluid delivery device of claim 1,wherein the drive unit includes a housing having a door, the door beingrotatable relative to the housing to cover the cartridge and seat thecartridge into position within the drive unit.
 16. The fluid deliverydevice of claim 1, wherein the cartridge includes a cover structureconfigured to be generally flush with a housing of the drive unit whenthe cartridge is fully inserted into the drive unit.
 17. The fluiddelivery device of claim 1 further comprising: a needle assembly havinga needle, the needle having a delivery end and a fluid coupling end, thefluid coupling end being fluidly disengaged from the fluid reservoir inan initial position, the delivery end extending past the bottom surfaceof the housing in a deployed position and the fluid coupling endextending through the pierceable septum and fluidly coupled with thefluid reservoir in the deployed position.
 18. A cartridge for insertionin a fluid delivery device, the cartridge comprising: a reservoir filledwith a fluid, the reservoir sealed at one end by a movable piston andsealed at another end by a pierceable septum; and one or more radialprojecting and circumferentially extending keyed features configured toalign and mate with one or more corresponding keyed features of thefluid delivery device allowing the cartridge to be inserted into thefluid delivery device.